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BACKGROUND: Although most health departments recognize the need for programs to reduce the risk of cardiovascular disease (CVD) among older, low-income women, they face numerous barriers to successfully implementing such programs. This paper explores counselors' attitudes and beliefs about patients and perceived barriers to implementing the North Carolina Well-Integrated Screening and Evaluation for Women Across the Nation (WISEWOMAN) program. METHODS: Health departments were assigned to provide patients with either an enhanced intervention (EI) or a minimum intervention (MI). Cross-sectional baseline and 12-month follow-up surveys were completed by health department counselors designated to deliver the MI or EI. Both surveys addressed counselors' beliefs about patients' motivation and attitudes, their counseling practices, and their personal diet and physical activity behaviors and attitudes. The follow-up survey also addressed opinions about the feasibility of long-term WISEWOMAN implementation. RESULTS: Counselors were skeptical about patients' motivation to improve their lifestyle, citing high perceived cost and burden. At follow-up, EI counselors reported having higher self-efficacy for counseling, incorporating more behavioral change strategies, and spending more time counseling than did counselors at MI sites. They were also more likely to report making healthful personal lifestyle choices. All counselors identified lack of time as a major barrier to counseling, and most cited obtaining low-cost medications for patients, ensuring that patients made follow-up visits, and implementing the program with existing staff as key challenges to the long-term sustainability of WISEWOMAN. CONCLUSIONS: Our findings provide insight into the organizational challenges of implementing a CVD risk-reduction program for low-income women. We discuss ways in which intervention and training programs can be improved. [ABSTRACT FROM AUTHOR]

Background: Many rural residents do not have access to high-quality nutrition counseling for high blood cholesterol. The objective of this study was to assess the effectiveness of an intervention program designed to facilitate dietary counseling for hypercholesterolemia by rural public health nurses.Methods: Eight health departments (216 participants) were randomized to give the special intervention (SI) and nine (252 participants) to give the minimal intervention (MI). The SI consisted of three individual diet counseling sessions given by a public health nurse, using a structured dietary intervention (Food for Heart Program), referral to a nutritionist if lipid goals were not achieved at 3-month follow-up, and a reinforcement phone call and newsletters. Diet was assessed by the Dietary Risk Assessment (DRA), a validated food frequency questionnaire, at baseline, 3-, and 12-month follow-up; blood lipids and weight were assessed at baseline, 3-, 6-, and 12-month follow-up.Results: Participants were largely female (71%), older (mean age 55), and white (80%). At 3-month follow-up, the average reduction (indicating dietary improvement) in total Dietary Risk Assessment score was 3.7 units greater in the SI group (95% confidence interval [CI] 1.9 to 5.5, P = 0.0006), while both groups experienced a similar reduction in blood cholesterol, 14.1 mg/dL (0.37 mmol/L) for SI and 14.5 mg/dL (0.38 mmol/L) for minimal intervention group (difference -0.4 mg/dL [-0.010 mmol/L], 95% CI -12.5 to 11.7 [-0.32 to 0.30], P = 0.9). At 12-month follow-up, the reduction in total Dietary Risk Assessment score was 2.1 units greater in the SI group (95% CI 0.8 to 3.5, P = 0.005), while the reduction in blood cholesterol was similar in both groups, 18.4 mg/dL (0.48 mmol/L) for SI and 15.6 mg/dL (0.40 mmol/L) for minimal intervention group (difference 2.8 mg/dL [0.07 mmol/L], 95% CI -7.5 to 13.1 [-0.19 to 0.34], P = 0.6). During follow-up, weight loss was greater in the SI group; the difference between groups was statistically significant at 3 (1.9 lb [0.86 kg], 95% CI 0.3 to 3.4 [0.14 to 1.55], P = 0.022) and 6 months (2.1 lb [0.95 kg], 95% CI 0.1 to 4.1 [0.04 to 1.86], P = 0.04). At 12 months, the difference was not significant (1.6 lb [0.73 kg], 95% CI -0.05 to 3.7 [-0.02 to 1.68], P = 0.13).Conclusions: Improvement in self-reported dietary intake was significantly greater in the SI group, while reduction in blood cholesterol was similar in both groups. [ABSTRACT FROM AUTHOR]

PURPOSE: A general measure of perceived diabetes and dietary competence (PDDC) was developed to assess a person's sense of confidence and perceived behavioral control in diabetes and dietary self-management. Internal structure, reliability, and construct validity were evaluated. METHODS: There were 2 samples of African American women with type 2 diabetes; 226 patients in the development sample and 225 patients in the validation sample. Factor analysis, Cronbach's coefficient alpha, and correlation analysis were used to assess reliability and validity of the PDDC measure. RESULTS: Three subscales were empirically determined by factor analysis: positive competence, negative dietary competence, and negative control. Cronbach's alphas for all subscales were good. Predicted relationships with measures of perceived health competence, self-efficacy, social support, and perceived dietary barriers were largely supported in construct validation. CONCLUSIONS: This study provides initial support for the internal reliability and validity of a perceived diabetes and dietary competence measure. Further research is needed to determine its validity in other samples of African Americans with type 2 diabetes and its clinical utility in evaluating diabetes self-management training. [ABSTRACT FROM AUTHOR]

Objective: To determine whether a culturally appropriate clinic- and community-based intervention for African-American women with type 2 diabetes will increase moderate-intensity physical activity (PA).Research Design and Methods: In this randomized controlled trial conducted at seven practices in central North Carolina, 200 African-American women, > or =40 years of age with type 2 diabetes, were randomized to one of three treatment conditions: clinic and community (group A), clinic only (group B), or minimal intervention (group C). The clinic-based intervention (groups A and B) consisted of four monthly visits with a nutritionist who provided counseling to enhance PA and dietary intake that was tailored to baseline practices and attitudes; the community-based intervention (group A) consisted of three group sessions and 12 monthly phone calls from a peer counselor and was designed to provide social support and reinforce behavior change goals; and the minimal intervention (group C) consisted of educational pamphlets mailed to participants. The primary study outcome was the comparison of PA levels between groups assessed at 6 and 12 months by accelerometer, which was worn while awake for 7 days.Results: Totals of 175 (88%) and 167 (84%) participants completed PA assessment at 6 and 12 months, respectively. For comparison of PA, the P value for overall group effect was 0.014. Comparing group A with C, the difference in the average adjusted mean for PA was 44.1 kcal/day (95% CI 13.1-75.1, P = 0.0055). Comparing group B with C, the difference in the average adjusted mean was 33.1 kcal/day (95% CI 3.3-62.8, P = 0.029). The intervention was acceptable to participants: 88% were very satisfied with clinic-based counseling to enhance PA, and 86% indicated that the peer counselor's role in the program was important.Conclusions: The intervention was associated with a modest enhancement of PA and was acceptable to participants. [ABSTRACT FROM AUTHOR]

PURPOSE: This paper describes a clinic- and community-based diabetes intervention program designed to improve dietary, physical activity, and self-care behaviors of older African American women with type 2 diabetes. It also describes the study to evaluate this program and baseline characteristics of participants.METHODS: The New Leaf.Choices for Healthy Living With Diabetes program consists of 4 clinic-based health counselor visits, a community intervention with 12 monthly phone calls from peer counselors, and 3 group sessions. A randomized, controlled trial to evaluate the effectiveness of this intervention is described.RESULTS: Seventeen focus groups of African American women were used to assessed the cultural relevance/acceptability of the intervention and measurement instruments. For the randomized trial, 200 African American women with type 2 diabetes were recruited from 7 practices in central North Carolina. Mean age was 59, mean diabetes duration was 10 years, and participants were markedly overweight and physically inactive.CONCLUSIONS: Participants found this program to be culturally relevant and acceptable. Its effects on diet, physical activity, and self-care behaviors will be assessed in a randomized trial. [ABSTRACT FROM AUTHOR]

Objective: Many African-American women are affected by diabetes and its complications, and culturally appropriate lifestyle interventions that lead to improvements in glycemic control are urgently needed. The aim of this qualitative study was to identify culturally relevant psychosocial issues and social context variables influencing lifestyle behaviors--specifically diet and physical activity--of southern African-American women with diabetes.Research Design and Methods: We conducted 10 focus group interviews with 70 southern African-American women with type 2 diabetes. Group interviews were audiotaped and transcripts were coded using qualitative data analysis software. A panel of reviewers analyzed the coded responses for emerging themes and trends.Results: The dominant and most consistent themes that emerged from these focus groups were 1) spirituality as an important factor in general health, disease adjustment, and coping; 2) general life stress and multi-caregiving responsibilities interfering with daily disease management; and 3) the impact of diabetes manifested in feelings of dietary deprivation, physical and emotional "tiredness," "worry," and fear of diabetes complications.Conclusions: Our findings suggest that influences on diabetes self-management behaviors of African-American women may be best understood from a sociocultural and family context. Interventions to improve self-management for this population should recognize the influences of spirituality, general life stress, multi-caregiving responsibilities, and the psychological impact of diabetes. These findings suggest that family-centered and church-based approaches to diabetes care interventions are appropriate. [ABSTRACT FROM AUTHOR]

Purpose: To examine the associations of role (localized prostate cancer (PCa) patient vs. their intimate partner), area deprivation index (ADI-higher scores indicating higher neighborhood deprivation levels), and race (Black/African American (AA) vs. White) with health behaviors and body mass index (BMI) among PCa patients and partners. The behaviors include smoking, alcohol consumption, diet quality, sedentary behaviors, and physical activity (PA)., Methods: This study used the baseline data collected in a clinical trial. Given the nested structure of the dyadic data, multi-level models were used., Results: Significant role-race interaction effects on smoking, ADI-race effects on alcohol consumption, and role-ADI effects on BMI were found. Meanwhile, patients smoked more cigarettes, decreased alcohol consumption, had less healthful diets, spent longer time watching TV, did fewer sedentary hobbies, had more confidence in PA, and had higher BMIs than their partners. High ADI was independently associated with lower odds of drinking alcohol, using computer/Internet, and doing non-walking PA, and higher BMI compared to low ADI controlling for role and race. Black/AA dyads had less smoking amount and alcohol consumption and higher sedentary time and BMI than White dyads when adjusted for role and ADI., Conclusions: This study identified significant interaction and main effects of role, ADI, or race on health behaviors and BMI., Implications for Cancer Survivors: Future behavioral interventions should address divergent individual needs between patients and partners, social and neighborhood barriers, and cultural indicators of racial groups to promote healthful behaviors and improve the quality of survivorship for PCa patients and partners., (© 2024. The Author(s).)

Purpose: To examine differences in lifestyle behavioral and psychosocial factors between rural African American women with Class 3 obesity and those with overweight, and Class 1-2 obesity., Design: Cross-sectional study., Setting: Rural Southeastern United States., Subjects: Participants included 289 African American women with a mean age of 56 years, 66% with a high school education or less, and a mean body mass index (BMI) of 38.6 kg/m 2 ; 35% (n = 102) were classified with Class 3 obesity., Measures: We objectively measured height, weight, and physical activity steps/day. Self-reported dietary and physical activity behaviors, general health-related quality of life, mental health, and social support were measured with validated surveys., Analysis: Chi-Square analysis for categorical variables and analysis of variance (ANOVA) - via multiple linear regression - for continuous variables., Results: There were no significant demographic differences between BMI groups, except for age, where women with Class 3 obesity were on average younger (51 vs 58 y, P < .001). Although dietary behaviors did not differ significantly between groups, we observed significant group differences in self-reported and objective measures of physical activity. The age-adjusted difference in means for self-reported total physical activity minutes/wk. was 91 minutes, with women categorized with Class 3 obesity reporting significantly fewer weekly minutes than those with overweight/Class 1-2 obesity (64.3 vs 156.4 min/wk. respectively, P < .01). Among psychosocial variables, only in the physical component scores of health-related quality of life did we find significant group differences - lower physical well-being among women with Class 3 obesity compared to those with overweight/Class 1-2 obesity ( P = .02)., Conclusion: For African American women with Class 3 obesity living in rural setting, these findings suggest behavioral weight loss interventions may need to target physical activity strategies that address physical, psychosocial, and environmental barriers., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Purpose: This study aimed to examine the effects of participant role (patient vs. partner), race (white vs. non-white), and place (less vs. more neighborhood deprivation) on health outcomes (quality of life [QOL] and symptoms) and stress-coping-related psychosocial factors (appraisals of illness and coping resources)., Methods: This descriptive study included 273 patients and their partners (dyads) who transitioned from PCa treatment to self-management. We used established, psychometrically sound measures to assess health outcomes and psychosocial factors and conducted multilevel modeling analyses., Results: Compared to partners, patients reported worse physical QOL; less frequent anxiety; less pain and fatigue; less bothersome hormonal problems; more bothersome urinary and sexual problems; greater self-efficacy; and more instrumental support. Compared to their white counterparts, non-white dyads reported better overall, emotional, and functional QOL; less depression; more positive appraisals, and greater self-efficacy. Compared to dyads in low ADI neighborhoods, dyads in high ADI (more deprived) neighborhoods reported worse social QOL; more bothersome urinary, sexual, and hormonal symptoms; and less interpersonal support. White patients reported the highest emotional support among all groups, while white partners reported the lowest emotional support., Conclusion: Our findings underscore the need to consider social determinants of health at multiple levels when investigating PCa disparities. Considering neighborhood-level socioeconomic factors, in addition to race and role, improves our understanding of the PCa disparities in QOL, symptoms, and psychosocial factors among patients and partners. Targeted multilevel supportive care interventions should tailor to the needs of racially diverse PCa patients and partners residing in deprived neighborhoods are needed., (© 2023 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.)

Purpose: Promoting positive health behaviors helps improve cancer survivors' health outcomes during survivorship; however, little is known about whether health behaviors differ by marital status. The purpose is to examine whether health behaviors and obesity among cancer survivors vary by marital status and whether the type of cancer and sociodemographic factors influence the relationship., Methods: We examined smoking, physical activity, and body mass index (BMI) among 1880 individuals diagnosed with prostate, breast, or colon cancer who were identified from the 2011-2017 Medical Expenditure Panel Survey (MEPS). We used Rao-Scott design-adjusted chi-square tests and weighted multivariable logistic regressions to achieve the research aims., Results: Current smoking behavior and BMI were significantly related to marital status. Survivors who had never married were the most likely to be current smokers across all cancer types. Married survivors were the most likely to be overweight or obese, while widowed survivors were the most likely to have a normal weight. The relationship between BMI and marital status varied by cancer type. Widowed colon cancer survivors were least likely to be overweight or obese; divorced/separated colon cancer survivors were most likely to be obese or overweight. Health behavior disparities were found among cancer survivors of different age, sex, race, and levels of education and income., Conclusions: There were relationships between marital status, health behaviors, and obesity among cancer survivors., Implications for Cancer Survivors: Our results suggested that relationship status and sociodemographic factors need to be considered in tailoring interventions to promote health behaviors among cancer survivors., (© 2022. The Author(s).)

Background: Food insecurity is associated with worse glycemic management for individuals with type 2 diabetes mellitus (T2DM), but whether medically tailored meals (MTM), a food insecurity intervention, can improve glycemic management is unclear., Objective: To describe the protocol for a trial assessing whether an MTM plus lifestyle intervention improves hemoglobin A1c (HbA1c) and participant-reported outcomes, relative to a food subsidy (money that can be spent on foods participants choose), for adults with both T2DM and food insecurity., Methods: The Food as Medicine for Diabetes (FAME-D) randomized clinical trial (goal n = 200) is a pragmatic trial with an active comparator. Participants, who will have T2DM and report food insecurity, will be randomly assigned to a 6-month MTM plus telephone-delivered lifestyle change intervention, or a 6-month food subsidy ($40/month). The primary outcome is HbA1c at 6 months. Secondary outcomes include HbA1c at 12 months to assess whether the intervention effect (if any) is sustained, along with weight, food insecurity, diabetes distress, and health-related quality of life. Qualitative analyses of semi-structured interviews will help understand why, how, and under what circumstances the intervention achieved its observed results., Conclusion: Results from FAME-D will help inform clinical management of food insecurity when it co-occurs with T2DM. Further, results may be useful as healthcare payors are considering coverage for MTM interventions., Clinicaltrials: gov: NCT04828785., Competing Interests: Declaration of Competing Interest SAB reports research grants from NIH, North Carolina Department of Health and Human Services, Blue Cross Blue Shield of North Carolina, and Feeding America, and personal fees from the Aspen Institute, Rockefeller Foundation, Gretchen Swanson Center for Nutrition, and Kaiser Permanente, outside of the submitted work. DJW reports serving on data monitoring committees for Novo Nordisk. JBB's contracted consulting fees and travel support for contracted activities are paid to the University of North Carolina by Novo Nordisk; clinical trial contracts are paid to the University of North Carolina by Dexcom, NovaTarg, Novo Nordisk, Sanofi, Tolerion and vTv Therapeutics; personal compensation for consulting services are received from Alkahest, Altimmune, Anji, AstraZeneca, Bayer, Biomea Fusion Inc., Boehringer-Ingelheim, CeQur, Cirius Therapeutics Inc., Dasman Diabetes Center (Kuwait), Eli Lilly, Fortress Biotech, GentiBio, Glycadia, Glyscend, Janssen, MannKind, Mediflix, Medscape, Mellitus Health, Moderna, Pendulum Therapeutics, Praetego, ReachMD, Stability Health, Valo, and Zealand Pharma; stock/options are provided by Glyscend, Mellitus Health, Pendulum Therapeutics, PhaseBio, Praetego, and Stability Health. GK has a family financial interest in a digital health company, Dimagi. Inc. and receives grant funding from NIH and Astra-Zeneca administered by the National Comprehensive Cancer Network. TCK has a family financial interest in a company that is a purveyor of healthy frozen meals, Equiti Foods, and receives grant funding from NIH, CDC, and the Duke Endowment. LMD reports consulting fees for WW International, Inc., and Omada Health, Inc. and stock options for JanaCare, Inc. and Omada Health, Inc. PWS reports funding from NIH research grants. JB, EO, BK, CF, and JT report employment by Community Servings but no conflicts., (Copyright © 2022 Elsevier Inc. All rights reserved.)

With the growing burden of diet-related chronic disease impacting the public's health, nutrition counseling in a primary care setting is essential and can be accomplished through brief and creative approaches. This article reviews an example of a brief dietary assessment and counseling tool and counseling strategies focusing on dietary behavior changes that emphasize impact on health outcomes, ease of behavior change, and affordability. These, plus integrating office supports, are practical ways to start the conversation about improving diet quality with patients. Collaborative efforts in nutrition care, particularly through collaboration with registered dietitians, present a valuable opportunity to meet the nutrition care needs of patients. Additionally, this article reviews screening for eating disorders, food insecurity, and dietary supplement use., Competing Interests: Disclosure The authors have nothing to disclose., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background: Men with localized prostate cancer often experience urinary, sexual, bowel, and hormonal symptoms; general distress; pain; fatigue; and sleep disturbance. For men in an intimate relationship, these symptoms disrupt couples' relationships and intimacy. The symptoms also reduce quality of life for both men and their partners, who are often their primary caregivers. Management of the negative effects of cancer and its treatment is a significantly under-addressed supportive care need for these men and their intimate partners. To address these unmet supportive care needs, our interdisciplinary team developed and pilot tested the usability and feasibility of an evidence-based, couple-focused, tailored eHealth intervention, "Prostate Cancer Education & Resources for Couples" (PERC). Based on the adapted stress and coping theoretical framework and developed with stakeholder involvement, PERC aims to improve quality of life for both men and their partners by enhancing their positive appraisals, self-efficacy, social support, and healthy behaviors for symptom management., Methods: We will test the efficacy of PERC using a population-based, geographically and demographically diverse cohort in a randomized controlled trial. Primary aim: Assess if patients and partners receiving PERC will report greater improvement in their cancer-related quality of life scores than those in the control group (usual care plus the National Cancer Institute prostate cancer website) at 4, 8, and 12 months post-baseline. Secondary aim: Test if patients and partners in PERC will report significantly more positive appraisals and higher levels of coping resources at follow-ups than those in the control group. Exploratory aim: Determine if patient race and ethnicity, education, type of treatment, or couples' relationship quality moderate the effects of PERC on patient and partner QOL at follow-ups., Discussion: This study will provide a novel model for self-managing chronic illness symptoms that impact couples' relationships, intimacy, and quality of life. It addresses the National Institute of Nursing Research's goal to develop and test new strategies for symptom self-management to help patients and caregivers better manage their illness and improve quality of life. It also responds to calls for programs from the Institute of Medicine and American Cancer Society to address treatment-related effects and improve survivors' QOL., Trial Registration: CT.gov NCT03489057., (© 2022. The Author(s).)

Objective: To assess the effect of dissemination and implementation of an intervention consisting of practice facilitation and a risk-stratified, population management dashboard on cardiovascular risk reduction for patients at high risk in small, primary care practices., Study Setting: A total of 219 small primary care practices (≤10 clinicians per site) across North Carolina with primary data collection from electronic health records (EHRs) from the fourth quarter of 2015 through the second quarter of 2018., Study Design: We performed a stepped-wedge, stratified, cluster randomized trial of a one-year intervention consisting of practice facilitation utilizing quality improvement techniques coupled with a cardiovascular dashboard that included lists of risk-stratified adults, aged 40-79 years and their unmet treatment opportunities. The primary outcome was change in 10-Year ASCVD Risk score among all patients with a baseline score ≥10 percent from baseline to 3 months postintervention., Data Collection/ Extraction Methods: Data extracts were securely transferred from practices on a nightly basis from their EHR to the research team registry., Principle Findings: ASCVD risk scores were assessed on 437 556 patients and 146 826 had a calculated 10-year risk ≥10 percent. The mean baseline risk was 23.4 percent (SD ± 12.6 percent). Postintervention, the absolute risk reduction was 6.3 percent (95% CI 6.3, 6.4). Models considering calendar time and stepped-wedge controls revealed most of the improvement (4.0 of 6.3 percent) was attributable to the intervention and not secular trends. In multivariate analysis, male gender, age >65 years, low-income (<$40 000), and Black race (P < .001 for all variables) were each associated with greater risk reductions., Conclusion: A risk-stratified, population management dashboard combined with practice facilitation led to substantial reductions of 10-year ASCVD risk for patients at high risk. Similar approaches could lead to effective dissemination and implementation of other new evidence, especially in rural and other under-resourced practices. Registration: ClinicalTrials.Gov 15-0479., (© Health Research and Educational Trust.)

Purpose: The purpose of this study was to examine the prevalences of CVD, CVD risk factors. and health behaviors among cancer survivor-spouse dyads, assess how these prevalences differ by role (survivor vs spouse) and gender, and report congruences in health behaviors between survivors and their spouses., Methods: We identified 1026 survivor-spouse dyads from the 2010-2015 Medical Expenditure Panel Survey. We used weighted multivariable logistic and linear regressions to analyze the data related to CVD, CVD risk factors, and health behaviors., Results: Survivors and spouses reported high prevalences of CVD and CVD risk factors but low engagement in healthy behaviors, including non-smoking, physical activity, and maintaining a healthy weight (proxy for healthy diet). Gender and role differences were significantly related to the prevalence of CVD, CVD risk factors, and health behaviors among survivors and spouses. From 39% to 88% of survivors and spouses were congruent in their current smoking status, physical activity engagement/disengagement, and BMI., Conclusion: Cancer survivors and spouses have high rates of CVD and CVD risk factors and poor engagement in healthful lifestyle behaviors. A high proportion of survivors and spouses were congruent in their current smoking status, physical activity engagement/disengagement, and BMI. Effective lifestyle interventions are needed for this high-risk population. Couple-focused interventions may be well-suited for these dyads and warrant further study., Implications for Cancer Survivors: Both cancer survivors and their spouses need to be non-moking, more physically active, and maintain normal BMI in order to reduce their high risk of CVD and CVD risk factors., (© 2020 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.)

Background: Experimental and observational research has suggested the potential for increased type 2 diabetes (T2D) risk among populations taking statins for the primary prevention of atherosclerotic cardiovascular disease (ASCVD). However, few studies have directly compared statin-associated benefits and harms or examined heterogeneity by population subgroups or assumed treatment effect. Thus, we compared ASCVD risk reduction and T2D incidence increases across 3 statin treatment guidelines or recommendations among adults without a history of ASCVD or T2D who were eligible for statin treatment initiation., Methods and Findings: Simulations were conducted using Markov models that integrated data from contemporary population-based studies of non-Hispanic African American and white adults aged 40-75 years with published meta-analyses. Statin treatment eligibility was determined by predicted 10-year ASCVD risk (5%, 7.5%, or 10%). We calculated the number needed to treat (NNT) to prevent one ASCVD event and the number needed to harm (NNH) to incur one incident case of T2D. The likelihood to be helped or harmed (LHH) was calculated as ratio of NNH to NNT. Heterogeneity in statin-associated benefit was examined by sex, age, and statin-associated T2D relative risk (RR) (range: 1.11-1.55). A total of 61,125,042 U.S. adults (58.5% female; 89.4% white; mean age = 54.7 years) composed our primary prevention population, among whom 13-28 million adults were eligible for statin initiation. Overall, the number of ASCVD events prevented was at least twice as large as the number of incident cases of T2D incurred (LHH range: 2.26-2.90). However, the number of T2D cases incurred surpassed the number of ASCVD events prevented when higher statin-associated T2D RRs were assumed (LHH range: 0.72-0.94). In addition, females (LHH range: 1.74-2.40) and adults aged 40-50 years (LHH range: 1.00-1.14) received lower absolute benefits of statin treatment compared with males (LHH range: 2.55-3.00) and adults aged 70-75 years (LHH range: 3.95-3.96). Projected differences in LHH by age and sex became more pronounced as statin-associated T2D RR increased, with a majority of scenarios projecting LHHs < 1 for females and adults aged 40-50 years. This study's primary limitation was uncertainty in estimates of statin-associated T2D risk, highlighting areas in which additional clinical and public health research is needed., Conclusions: Our projections suggest that females and younger adult populations shoulder the highest relative burden of statin-associated T2D risk., Competing Interests: The authors have declared that no competing interests exist.

Purpose: Dietary assessment is vital to inform individualized nutrition care and to evaluate the success of interventions aimed at improving diet for participants in cardiac rehabilitation (CR) programs. The purpose of this study was to assess the validity and reliability of an instrument developed to reflect current evidence-informed dietary recommendations advocated to reduce cardiovascular risk., Methods: This study was conducted at a single CR program at the University of North Carolina, Chapel Hill. Two dietary assessments were administered: Picture Your Plate (PYP) and a reference instrument, the Harvard/Willett Food Frequency Questionnaire (HWFFQ). The PYP is a modification of a previously validated instrument, the Dietary Risk Assessment-New Leaf (DRA-New Leaf). Concurrent validity was assessed by comparing the PYP total score with 3 diet quality indexes (Alternative Health Eating Index [AHEI], Dietary Approaches to Stop Hypertension [DASH], and Alternative Mediterranean Diet [aMED]) calculated from the HWFFQ and by assessment of agreement in tertile cross-classification. An intraclass correlation (ICC) was calculated to assess test-retest reliability., Results: Among the 108 participants, crude and adjusted Spearmen correlation coefficients between the PYP and 3 indexes of dietary quality were AHEI-2010 (0.71-0.72), DASH (0.70-0.71), and aMED (0.52-0.58) (P < .0001, all comparisons). Agreement of tertiles comparing PYP and AHEI-2010 was 67% and the score in opposite tertiles was 6%. The weighted kappa value (κw) = 0.71. The test-retest ICC was 0.91 (95% CI, 0.85-0.93; n = 91)., Conclusions: Results support the PYP as a valid and reliable dietary assessment tool for use in CR programs. Continued research in additional CR program populations is recommended.

Purpose: Few population-based studies have examined the prevalence of cardiovascular disease (CVD) and risk factors, quality of life (QOL), and health behaviors of cancer survivors and their spouses. This case-control study aimed to fill this gap using the data from a set of large-scale surveys of individuals and families across the USA., Methods: Data were obtained from the 2010-2015 Medical Expenditure Panel Survey (MEPS). Using one-to-many (1:5) propensity score matching, we identified cancer survivors (N = 1037) and noncancer-matched controls (N = 5185), as well as survivor spouses (N = 1038) and matched controls (N = 5190). We used weighted multivariable logistic and linear regressions to examine the categorical and numerical outcomes., Results: Compared with noncancer controls, survivors have higher rates of stroke (p < .05), hypertension (p < .05), high cholesterol (p < .01), fair or poor health (p < .0001), and report self-reported worse physical QOL scores (PCS) (p < .0001). A higher percentage of survivors report receiving BP checks (p < .01), serum cholesterol assessments (p < .001), routine physical checkups (p < .01), blood stool tests (p < .05), colonoscopies (p < .0001), and flu vaccinations (p < .05). Survivor spouses, compared to their respective matched controls, reported higher rates of serum cholesterol testing (p < .001), routine physical checkups (p < .01), and flu vaccinations (p < .01)., Conclusions: Compared to the general population, cancer survivors are at higher risk for CVD, report worse physical QOL, and, along with their spouses, more frequently receive certain preventive health care services., Implications for Cancer Survivors: There is a need for intervention to more fully engage cancer survivors and spouses in lifestyle behavior change associated with decreased CVD and related risk factors and improved QOL.

Background: The diet quality of adults living in the United States has improved overtime. We aim to determine whether diet quality among adults with diabetes mellitus has changed over time, and to examine trends in socioeconomic disparities in diet quality., Methods: Repeated cross-sectional analysis of eight National Health and Nutrition Examination Survey (NHANES) cycles (1999-2000 through 2013-2014). We included 5882 adult participants (age 20 or older) with diabetes mellitus (type 1 or 2) who completed 24-h dietary recalls. Diet quality was measured by the Healthy Eating Index 2010 (HEI) score (range 0-100, higher scores indicate better diet quality). We tested whether there were differences in diet quality across education, income, and food security categories, and whether any differences changed over time, using weighted linear regression models accounting for the complex survey design and adjusted for age, gender, and race/ethnicity., Results: Twenty nine percent of US adults with diabetes had less than a high school diploma, 17% had income < 100% of federal poverty level, and 15% reported food insecurity. Average adjusted HEI score increased from 49.4 to 52.4 over the study period (p for trend = 0.003). We observed differences in HEI between high and low education (4.1, 95% CI 3.0-5.3), high and low income (3.7, 95%CI 2.4-5.0) and food secure relative to food insecure (2.1, 95% CI 0.8-3.3). These differences did not improve over time for education (p = 0.56), income (p = 0.65) or food security (p = 0.39) categories., Conclusions: Diet quality for adults with diabetes in the U.S. has improved overall; however, substantial disparities exist and have not improved. A concerted effort to improve diet quality in vulnerable groups may be needed.

Objective: Evidence for the cardioprotective effects of a Mediterranean-style (Med-style) diet is strong, however few Med-style dietary interventions have been developed for and tested among Hispanic Americans (HAs), especially younger HAs of reproductive age whose dietary habits may strongly influence dietary intake for all family members., Design: We adapted a previously tested and evidence-informed lifestyle intervention to reduce CVD risk and evaluated its feasibility, acceptability, and effects on self-reported lifestyle behaviors in this study enrolling low-income HA women attending a Title X family planning clinic in eastern North Carolina. The 3-month long intervention, given to all participants, promoted a Med-style dietary pattern with a focus on increasing consumption of foods commonly consumed by HA that have high quality dietary fats (polyunsaturated and monounsaturated fats primarily from plant sources and fish) and carbohydrates (fruits, vegetables, and whole grains). The intervention also recommended increasing physical activity and was given during 2 face-to-face counseling sessions and 2 telephone counseling sessions. Major outcomes were engagement with study activities and intervention acceptability; lifestyle behavior change at 3-month follow-up is also reported., Results: Baseline characteristics (n = 36) were: mean age 33 years, 35 (97%) without health insurance, 32 (89%) born in Mexico, and mean BMI 30 kg/m 2 . Engagement was high among the 36 participants with 33 (92%) completing the intervention and follow-up measures. At follow-up, most participants thought the intervention was helpful (range: 85-100%) and acceptable (100% agreed 'I would recommend the program to others'). The mean dietary fat quality score improved by 0.5 units (95% CI: 0.0-1.1) and the mean fruit-vegetable servings/day improved by 0.7/day (95% CI: 0.1-1.3)., Conclusion: Intervention engagement and acceptability were high and there was improvement in self-reported dietary behaviors. This type of Med-style dietary pattern intervention should be evaluated in randomized trials enrolling HAs at risk for CVD.

Aims: To conduct a meta-analysis of statin-associated type 2 diabetes mellitus (T2D) risk among randomized controlled trials (RCTs) and observational studies (OBSs), excluding studies conducted among secondary prevention populations., Methods: Studies were identified by searching PubMed (1994-present) and EMBASE (1994-present). Articles had to meet the following criteria: (1) follow-up >one year; (2) >50% of participants free of clinically diagnosed ASCVD; (3) adult participants ≥30 years old; (4) reported statin-associated T2D effect estimates; and (5) quantified precision using 95% confidence interval. Data were pooled using random-effects model., Results: We identified 23 studies (35% RCTs) of n = 4,012,555 participants. OBS participants were on average younger (mean difference = 6.2 years) and had lower mean low-density lipoprotein cholesterol (LDL-C, mean difference = 20.6 mg/dL) and mean fasting plasma glucose (mean difference = 5.2 mg/dL) compared to RCT participants. There was little evidence for publication bias (P > 0.1). However, evidence of heterogeneity was observed overall and among OBSs and RCTs (P Cochran  = <0.05). OBS designs, younger baseline mean ages, lower LDL-C concentrations, and high proportions of never or former smokers were significantly associated with increased statin-associated T2D risk., Conclusions: Potentially elevated statin-associated T2D risk in younger populations with lower LDL-C merits further investigation in light of evolving statin guidelines targeting primary prevention populations., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Reports on the burden of heart failure (HF) have largely omitted HF diagnosed in outpatient settings. We quantified annual incidence rates ([IR] per 1,000 person years) of HF identified in ambulatory clinics, emergency departments (EDs), and during hospital stays in a national probability sample of Medicare beneficiaries from 2008 to 2014, by age and race/ethnicity. A 20% random sample of Medicare beneficiaries ages ≥65 years with continuous Medicare Parts A, B, and D coverage was used to estimate annual IRs of HF identified using International Classification of Diseases, Ninth Revision, Clinical Modification codes. Of the 681,487 beneficiaries with incident HF from 2008 to 2014, 283,451 (41%) presented in ambulatory clinics, 76,919 (11%) in EDs, and 321,117 (47%) in hospitals. Overall, incidence of HF in ambulatory clinics decreased from 2008 (IR 22.2, 95% confidence interval [CI] 22.0, 22.4) to 2014 (IR 15.0, 95% CI 14.8, 15.1). Similarly, incidence of HF-related ED visits without an admission to the hospital decreased somewhat from 2008 (IR 5.5, 95% CI 5.4, 5.6) to 2012 (IR 4.2, 95% CI 4.1, 4.3) and stabilized from 2013 to 2014. Similar to previous reports, HF hospitalizations, both International Classification of Diseases, Ninth Revision, Clinical Modification code 428.x in the primary and any position, decreased over the study period. More than half of all new cases of HF in Medicare beneficiaries presented in an ambulatory clinic or ED. The overall incidence of HF decreased from 2008 to 2014, regardless of health-care setting. In conclusion, consideration of outpatient HF is warranted to better understand the burden of HF and its temporal trends., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Although vegetable consumption associates with decreased risk for a variety of diseases, few Americans meet dietary recommendations for vegetable intake. TAS2R38 encodes a taste receptor that confers bitter taste sensing from chemicals found in some vegetables. Common polymorphisms in TAS2R38 lead to coding substitutions that alter receptor function and result in the loss of bitter taste perception. Our study examined whether bitter taste perception TAS2R38 diplotypes associated with vegetable consumption in participants enrolled in either an enhanced or a minimal nutrition counseling intervention. DNA was isolated from the peripheral blood cells of study participants (N = 497) and analyzed for polymorphisms. Vegetable consumption was determined using the Block Fruit and Vegetable screener. We tested for differences in the frequency of vegetable consumption between intervention and genotype groups over time using mixed effects models. Baseline vegetable consumption frequency did not associate with bitter taste diplotypes ( P = 0.937), however after six months of the intervention, we observed an interaction between bitter taste diplotypes and time ( P = 0.046). Participants in the enhanced intervention increased their vegetable consumption frequency ( P = 0.020) and within this intervention group, the bitter non-tasters and intermediate-bitter tasters had the largest increase in vegetable consumption. In contrast, in the minimal intervention group, the bitter tasting participants reported a decrease in vegetable consumption. Bitter-non tasters and intermediate-bitter tasters increased vegetable consumption in either intervention more than those who perceive bitterness. Future precision medicine applications could consider genetic variation in bitter taste perception genes when designing dietary interventions., (Copyright © 2018 Calancie et al.)

As part of the Heart Healthy Lenoir Project, we developed a practice level intervention to improve blood pressure control. The goal of this study was: (i) to determine if single nucleotide polymorphisms (SNPs) that associate with blood pressure variation, identified in large studies, are applicable to blood pressure control in subjects from a rural population; (ii) to measure the association of these SNPs with subjects' responsiveness to the hypertension intervention; and (iii) to identify other SNPs that may help understand patient-specific responses to an intervention. We used a combination of candidate SNPs and genome-wide analyses to test associations with either baseline systolic blood pressure (SBP) or change in systolic blood pressure one year after the intervention in two genetically defined ancestral groups: African Americans (AA) and Caucasian Americans (CAU). Of the 48 candidate SNPs, 13 SNPs associated with baseline SBP in our study; however, one candidate SNP, rs592582, also associated with a change in SBP after one year. Using our study data, we identified 4 and 15 additional loci that associated with a change in SBP in the AA and CAU groups, respectively. Our analysis of gene-age interactions identified genotypes associated with SBP improvement within different age groups of our populations. Moreover, our integrative analysis identified AQP4-AS1 and PADI2 as genes whose expression levels may contribute to the pleiotropy of complex traits involved in cardiovascular health and blood pressure regulation in response to an intervention targeting hypertension. In conclusion, the identification of SNPs associated with the success of a hypertension treatment intervention suggests that genetic factors in combination with age may contribute to an individual's success in lowering SBP. If these findings prove to be applicable to other populations, the use of this genetic variation in making patient-specific interventions may help providers with making decisions to improve patient outcomes. Further investigation is required to determine the role of this genetic variance with respect to the management of hypertension such that more precise treatment recommendations may be made in the future as part of personalized medicine., Competing Interests: The authors declare no conflict of interest. The founding sponsors had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript, and in the decision to publish the results.

Objective: The aim of this work was to estimate agreement of self-reported heart failure (HF) with physician-diagnosed HF and compare the prevalence of HF according to method of ascertainment., Methods and Results: ARIC cohort members (60-83 years of age) were asked annually whether a physician indicated that they have HF. For those self-reporting HF, physicians were asked to confirm their patients' HF status. Physician-diagnosed HF included surveillance of hospitalized HF and hospitalized and outpatient HF identified in administrative claims databases. We estimated sensitivity, specificity, positive predicted value, kappa, prevalence and bias-adjusted kappa (PABAK), and prevalence. Compared with physician-diagnosed HF, sensitivity of self-report was low (28%-38%) and specificity was high (96%-97%). Agreement was poor (kappa 0.32-0.39) and increased when adjusted for prevalence and bias (PABAK 0.73-0.83). Prevalence of HF measured by self-report (9.0%), ARIC-classified hospitalizations (11.2%), and administrative hospitalization claims (12.7%) were similar. When outpatient HF claims were included, prevalence of HF increased to 18.6%., Conclusions: For accurate estimates HF burden, self-reports of HF are best confirmed by means of appropriate diagnostic tests or medical records. Our results highlight the need for improved awareness and understanding of HF by patients, because accurate patient awareness of the diagnosis may enhance management of this common condition., (Published by Elsevier Inc.)

Background: Few studies have been conducted in rural areas assessing the influence of community-level environmental factors on residents' success improving lifestyle behaviors., Objective: Our aim was to examine whether 6-month changes in diet, physical activity, and weight were moderated by the food and physical activity environment in a rural adult population receiving an intervention designed to improve diet and physical activity., Design: We examined associations between self-reported and objectively measured changes in diet, physical activity, and weight, and perceived and objectively measured food and physical activity environments. Participants were followed for 6 months., Participants/setting: Participants were enrolled in the Heart Healthy Lenoir Project, a lifestyle intervention study conducted in Lenoir County, located in rural southeastern North Carolina. Sample sizes ranged from 132 to 249, depending on the availability of the data., Intervention: Participants received four counseling sessions that focused on healthy eating (adapted Mediterranean diet pattern) and increasing physical activity., Potential Moderating Factors: Density of and distance to food and physical activity venues, modified food environment index, Walk Score, crime, and perceived nutrition and physical activity neighborhood barriers were the potential mediating factors., Outcome Measures: Diet quality, physical activity, and weight loss were the outcomes measured., Statistical Analyses: Statistical analyses included correlation and linear regression and controlling for potential confounders (baseline values of the dependent variables, age, race, education, and sex)., Results: In adjusted analysis, there was an inverse association between weight change and the food environment, suggesting that participants who lived in a less-healthy food environment lost more weight during the 6-month intervention period (P=0.01). Also, there was a positive association between self-reported physical activity and distance to private gyms (P=0.04) and an inverse association between private gym density and pedometer-measured steps (P=0.03), indicating that those who lived farther from gyms and in areas with lower density of gyms had greater increases in physical activity and steps, respectively., Conclusions: Contrary to our hypotheses, results indicated that those living in less-favorable food and physical activity environments had greater improvements in diet, physical activity, and weight, compared to those living in more favorable environments. Additional research should be undertaken to address these paradoxical findings and, if confirmed, to better understand them., (Copyright © 2017 Academy of Nutrition and Dietetics. Published by Elsevier Inc. All rights reserved.)

The Southeastern United States has the highest prevalence of hypertension and African Americans have disproportionately worse blood pressure control. The authors sought to evaluate the effect of a multicomponent practice-based quality improvement intervention on lowering mean systolic blood pressure (SBP) at 12 and 24 months compared with baseline among 525 patients, and to assess for a differential effect of the intervention by race (African Americans vs white). At 12 months, both African Americans (-5.0 mm Hg) and whites (-7.8 mm Hg) had a significant decrease in mean SBP compared with baseline, with no significant between-group difference. Similarly, at 24 months, mean SBP decreased in both African Americans (-6.0 mm Hg) and whites (-7.2 mm Hg), with no significant difference between groups. Notably, no significant racial disparity in mean SBP at baseline was shown. The intervention was effective in lowering mean SBP in both African Americans and whites but there was no differential effect of the intervention by race., (©2016 Wiley Periodicals, Inc.)

Objective: To examine weight change by diabetes status among participants receiving a Mediterranean-style diet, physical activity, and weight loss intervention adapted for delivery in the southeastern USA, where rates of cardiovascular disease (CVD) are disproportionately high., Research Design and Methods: The intervention included: Phase I (months 1-6), an individually tailored intervention promoting a Mediterranean-style dietary pattern and increased walking; Phase II (months 7-12), option of a 16-week weight loss intervention for those with BMI≥25 kg/m 2 offered as 16 weekly group sessions or 5 group sessions and 10 phone calls, or a lifestyle maintenance intervention; and Phase III (months 13-24), weight loss maintenance intervention for those losing ≥8 pounds with all others receiving a lifestyle maintenance intervention. Weight change was assessed at 6, 12, and 24-month follow-up., Results: Baseline characteristics (n=339): mean age 56, 77% female, 65% African-American, 124 (37%) with diabetes; mean weight 103 kg for those with diabetes and 95 kg for those without. Among participants with diabetes, average weight change was -1.2 kg (95% CI -2.1 to -0.4) at 6 months (n=92), -1.5 kg (95% CI -2.9 to -0.2) at 12 months (n=96), and -3.7 kg (95% CI -5.2 to -2.1) at 24 months (n=93). Among those without diabetes, weight change was -0.4 kg (95% CI -1.4 to 0.6) at 24 months (n=154)., Conclusions: Participants with diabetes experienced sustained weight loss at 24-month follow-up. High-risk US populations with diabetes may experience clinically important weight loss from this type of lifestyle intervention., Trial Registration Number: NCT01433484., Competing Interests: Competing interests: None declared.

Objective: To develop and test a family-centered behavioral weight loss intervention for African American adults with type 2 diabetes., Methods: In this randomized trial, dyads consisting of an African American adult with overweight or obesity and type 2 diabetes (index participant) paired with a family partner with overweight or obesity but not diagnosed with diabetes were assigned in a 2:1 ratio to a 20-week special intervention (SI) or delayed intervention (DI) control group. The primary outcome was weight loss among index participants at the 20-week follow-up., Results: One hundred eight participants (54 dyads-36 (SI) and 18 (DI) dyads) were enrolled: 81% females; mean age, 51 years; mean weight,103 kg; and mean BMI, 37 kg/m 2 . At post-intervention, 96 participants (89%) returned for follow-up measures. Among index participants, mean difference in weight loss between groups was -5.0 kg, P <0.0001 (-3.6 kg loss among SI; 1.4 kg gain in DI). SI index participants showed significantly greater improvements in hemoglobin A1c, depressive symptoms, family interactions, and dietary, physical activity, and diabetes self-care behaviors. SI family partners also had significant weight loss (-3.9 kg (SI) vs. -1.0 kg (DI), P = 0.02)., Conclusions: A family-centered, behavioral weight loss intervention led to clinically significant short-term weight loss among family dyads., Competing Interests: There are no conflicts of interest to declare., (© 2016 The Obesity Society.)

Background: As Americans commonly consume restaurant foods with poor dietary quality, effective interventions are needed to improve food choices at restaurants., Purpose: To design and evaluate a restaurant-based intervention to help customers select and restaurants promote heart healthy menu items with healthful fats and high quality carbohydrates., Methods: The intervention included table tents outlining 10 heart healthy eating tips, coupons promoting healthy menu items, an information brochure, and link to study website. Pre and post intervention surveys were completed by restaurant managers and customers completed a brief "intercept" survey., Results: Managers (n = 10) reported the table tents and coupons were well received, and several noted improved personal nutrition knowledge. Overall, 4214 coupons were distributed with 1244 (30%) redeemed. Of 300 customers surveyed, 126 (42%) noticed the table tents and of these, 115 (91%) considered the nutrition information helpful, 42 (33%) indicated the information influenced menu items purchased, and 91 (72%) reported the information will influence what they order in the future., Discussion: The intervention was well-received by restaurant managers and positively influenced menu item selection by many customers., Translation to Health Education Practice: Further research is needed to assess effective strategies for scaling up and sustaining this intervention approach.

Background: Because residents of the southeastern United States experience disproportionally high rates of cardiovascular disease (CVD), it is important to develop effective lifestyle interventions for this population., Methods: The primary objective was to develop and evaluate a dietary, physical activity (PA) and weight loss intervention for residents of the southeastern US. The intervention, given in eastern North Carolina, was evaluated in a 2 year prospective cohort study with an embedded randomized controlled trial (RCT) of a weight loss maintenance intervention. The intervention included: Phase I (months 1-6), individually-tailored intervention promoting a Mediterranean-style dietary pattern and increased walking; Phase II (months 7-12), option of a 16-week weight loss intervention for those with BMI ≥ 25 kg/m(2) offered in 2 formats (16 weekly group sessions or 5 group sessions and 10 phone calls) or a lifestyle maintenance intervention; and Phase III (months 13-24), weight loss maintenance RCT for those losing ≥ 8 lb with all other participants receiving a lifestyle maintenance intervention. Change in diet and PA behaviors, CVD risk factors, and weight were assessed at 6, 12, and 24 month follow-up., Results: Baseline characteristics (N = 339) were: 260 (77 %) females, 219 (65 %) African Americans, mean age 56 years, and mean body mass index 36 kg/m(2). In Phase I, among 251 (74 %) that returned for 6 month follow-up, there were substantial improvements in diet score (4.3 units [95 % CI 3.7 to 5.0]), walking (64 min/week [19 to 109]), and systolic blood pressure (-6.4 mmHg [-8.7 to -4.1]) that were generally maintained through 24 month follow-up. In Phase II, 138 (57 group only, 81 group/phone) chose the weight loss intervention and at 12 months, weight change was: -3.1 kg (-4.9 to -1.3) for group (N = 50) and -2.1 kg (-3.2 to -1.0) for group/phone combination (N = 75). In Phase III, 27 participants took part in the RCT. At 24 months, weight loss was -2.1 kg (-4.3 to 0.0) for group (N = 51) and -1.1 kg (-2.7 to 0.4) for combination (N = 72). Outcomes for African American and whites were similar., Conclusions: The intervention yielded substantial improvement in diet, PA, and blood pressure, but weight loss was modest., Trial Registration: clinicaltrials.gov Identifier: NCT01433484.

Background: Low-income women of reproductive age are at increased risk for obesity and resulting increases in the risk of maternal/fetal complications and mortality and morbidity. Very few weight-loss interventions, however, have been targeted to this high-risk group. Based on the high prevalence of social media use among young and low-income individuals and previous successes using group formats for weight-loss interventions, the use of social media as a platform for weight-loss intervention delivery may benefit low-income women of reproductive age., Objective: Examine the feasibility of delivering group-based weight-loss interventions to low-income women of reproductive age using face-to-face meetings and Web-based modalities including social media., Methods: Participants attended a family planning clinic in eastern North Carolina and received a 5-month, group- and Web-based, face-to-face weight-loss intervention. Measures were assessed at baseline and 20 weeks., Results: Forty participants enrolled, including 29 (73%) African American women. The mean body mass index of enrollees was 39 kg/m(2). Among the 12 women who completed follow-up, mean weight change was -1.3 kg. Participation in the intervention was modest and retention at 5 months was 30%. Returnees suggested sending reminders to improve participation and adding activities to increase familiarity among participants., Conclusions: Engagement with the intervention was limited and attrition was high. Additional formative work on the barriers and facilitators to participation may improve the intervention's feasibility with low-income women of reproductive age.

Background: Health coaching is increasingly important in patient-centered medical homes., Objectives: Describe formative evaluation results and lessons learned from implementing health coaching to improve hypertension self-management in rural primary care., Methods: A hypertension collaborative was formed consisting of six primary care sites. Twelve monthly health coaching phone calls were attempted for 487 participants with hypertension., Lessons Learned: Participant engagement was challenging; 58% remained engaged, missing fewer than three consecutive calls. Multivariate analyses revealed that older age (odds ratio [OR], 1.03; 95% confidence interval [CI], 1.01-1.05), African American race (O,R 1.73; 95% CI, 1.15-2.60), greater number of comorbidities (OR, 1.17; 95% CI, 1.05-1.30) and receiving coaching closer to enrollment (OR, 5.03; 95% CI, 2.53-9.99) were correlated independently with engagement. Participants reported the coaching valuable; 96% would recommend health coaching to others., Conclusions: Health coaching in hypertension care can be successful strategy for engaging more vulnerable groups. A more tailored approach may improve engagement with counseling.

We examined cross-sectional associations among neighborhood- and individual-level factors related to a healthful lifestyle and dietary intake, physical activity (PA), and support for obesity prevention polices in rural eastern North Carolina adults. We examined perceived neighborhood barriers to a healthful lifestyle, and associations between neighborhood barriers to healthy eating and PA, participants' support for seven obesity prevention policies, and dependent variables of self-reported dietary and PA behaviors, and measured body mass index (BMI) (n = 366 study participants). We then used participants' residential addresses and Geographic Information Systems (GIS) software to assess neighborhood-level factors related to access to healthy food and PA opportunities. Correlational analyses and adjusted linear regression models were used to examine associations between neighborhood-level factors related to a healthful lifestyle and dietary and PA behaviors, BMI, and obesity prevention policy support. The most commonly reported neighborhood barriers (from a list of 18 potential barriers) perceived by participants included: not enough bicycle lanes and sidewalks, not enough affordable exercise places, too much crime, and no place to buy a quick, healthy meal to go. Higher diet quality was inversely related to perceived and GIS-assessed neighborhood nutrition barriers. There were no significant associations between neighborhood barriers and PA. More perceived neighborhood barriers were positively associated with BMI. Support for obesity prevention policy change was positively associated with perceptions of more neighborhood barriers. Neighborhood factors that promote a healthful lifestyle were associated with higher diet quality and lower BMI. Individuals who perceived more neighborhood-level barriers to healthy eating and PA usually supported policies to address those barriers. Future studies should examine mechanisms to garner such support for health-promoting neighborhood changes.

Background: Cardiovascular disease (CVD) screening in Title X settings can identify low-income women at risk of future chronic disease. This study examines follow-up related to newly identified CVD risk factors in a Title X setting., Methods: Female patients at a North Carolina Title X clinic were screened for CVD risk factors (n=462) and 167/462 (36.1%) were rescreened one year later. Clinical staff made protocol-driven referrals for women identified with newly diagnosed CVD risk factors. We used paired t-tests and chi square tests to compare screening and rescreening results (two-tailed, p<0.05)., Results: Among 11 women in need of referrals for newly diagnosed hypertension or diabetes, 9 out of 11 (81.8%) were referred, and 2 of 11 (18.2%) completed referrals. Among hypertensive women who were rescreened (n=21), systolic blood pressure decreased (139 to 132 mmHg, p=0.001) and diastolic blood pressure decreased (90 to 83 mmHg, p=0.006). Hemoglobin A1c did not improve among rescreened diabetic women (n=5, p=0.640). Among women who reported smoking at enrollment, 129 of 148 (87.2%) received cessation counseling and 8 of 148 (5.4%) accepted tobacco quitline referrals. Among smokers, 53 out of 148 (35.8%) were rescreened and 11 of 53 (20.8%) reported nonsmoking at that time. Among 188 women identified as obese at enrollment, 22 (11.7%) scheduled nutrition appointments, but only one attended. Mean weight increased from 221 to 225 pounds (p 0<.05) among 70 out of 188 (37.2%) obese women who were rescreened., Conclusions: The majority of women in need of referrals for CVD risk factors received them. Few women completed referrals. Future research should examine barriers and facilitators of referral care among low-income women.

Objectives: This study explored the criterion-related validity and test-retest reliability of the modified RESIDential Environment physical activity questionnaire and whether the instrument's validity varied by body mass index, education, race/ethnicity, or employment status., Design: Validation study using baseline data collected for randomized trial of a weight loss intervention., Methods: Participants recruited from health departments wore an ActiGraph accelerometer and self-reported non-occupational walking, moderate and vigorous physical activity on the modified RESIDential Environment questionnaire. We assessed validity (n=152) using Spearman correlation coefficients, and reliability (n=57) using intraclass correlation coefficients., Results: When compared to steps, moderate physical activity, and bouts of moderate/vigorous physical activity measured by accelerometer, these questionnaire measures showed fair evidence for validity: recreational walking (Spearman correlation coefficients 0.23-0.36), total walking (Spearman correlation coefficients 0.24-0.37), and total moderate physical activity (Spearman correlation coefficients 0.18-0.36). Correlations for self-reported walking and moderate physical activity were higher among unemployed participants and women with lower body mass indices. Generally no other variability in the validity of the instrument was found. Evidence for reliability of RESIDential Environment measures of recreational walking, total walking, and total moderate physical activity was substantial (intraclass correlation coefficients 0.56-0.68)., Conclusions: Evidence for questionnaire validity and reliability varied by activity domain and was strongest for walking measures. The questionnaire may capture physical activity less accurately among women with higher body mass indices and employed participants. Capturing occupational activity, specifically walking at work, may improve questionnaire validity., (Copyright © 2014 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.)

Greater accessibility to geospatial technologies has led to a surge of spatialized public health research, much of which has focused on food environments. The purpose of this study was to analyze differing spatial measures of exposure to supermarkets and farmers׳ markets among women of reproductive age in eastern North Carolina. Exposure measures were derived using participant-defined neighborhoods, investigator-defined road network neighborhoods, and activity spaces incorporating participants׳ time space behaviors. Results showed that mean area for participant-defined neighborhoods (0.04 sq. miles) was much smaller than 2.0 mile road network neighborhoods (3.11 sq. miles) and activity spaces (26.36 sq. miles), and that activity spaces provided the greatest market exposure. The traditional residential neighborhood concept may not be particularly relevant for all places. Time-space approaches capturing activity space may be more relevant, particularly if integrated with mixed methods strategies., (Copyright © 2014 Elsevier Ltd. All rights reserved.)

Importance: Most primary care clinicians lack the skills and resources to offer effective lifestyle and medication (L&M) counseling to reduce coronary heart disease (CHD) risk. Thus, effective and feasible CHD prevention programs are needed for typical practice settings., Objective: To assess the effectiveness, acceptability, and cost-effectiveness of a combined L&M intervention to reduce CHD risk offered in counselor-delivered and web-based formats., Design, Setting, and Participants: A comparative effectiveness trial in 5 diverse family medicine practices in North Carolina. Participants were established patients, aged 35 to 79 years, with no known cardiovascular disease, and at moderate to high risk for CHD (10-year Framingham Risk Score [FRS], ≥10%)., Interventions: Participants were randomized to counselor-delivered or web-based format, each including 4 intensive and 3 maintenance sessions. After randomization, both formats used a web-based decision aid showing potential CHD risk reduction associated with L&M risk-reducing strategies. Participants chose the risk-reducing strategies they wished to follow., Main Outcomes and Measures: The primary outcome was within-group change in FRS at 4-month follow-up. Other measures included standardized assessments of blood pressure, blood lipid levels, lifestyle behaviors, and medication adherence. Acceptability and cost-effectiveness were also assessed. Outcomes were assessed at 4 and 12 months., Results: Of 2274 screened patients, 385 were randomized (192 counselor; 193 web): mean age, 62 years; 24% African American; and mean FRS, 16.9%. Follow-up at 4 and 12 months included 91% and 87% of the randomized participants, respectively. There was a sustained reduction in FRS at both 4 months (primary outcome) and 12 months for both counselor-based (-2.3% [95% CI, -3.0% to -1.6%] and -1.9% [95% CI, -2.8% to -1.1%], respectively) and web-based groups (-1.5% [95% CI, -2.2% to -0.9%] and -1.7% [95% CI, -2.6% to -0.8%] respectively). At 4 months, the adjusted difference in FRS between groups was -1.0% (95% CI, -1.8% to -0.1%) (P = .03), and at 12 months, it was -0.6% (95% CI, -1.7% to 0.5%) (P = .30). The 12-month costs from the payer perspective were $207 and $110 per person for the counselor- and web-based interventions, respectively., Conclusions and Relevance: Both intervention formats reduced CHD risk through 12-month follow-up. The web format was less expensive., Trial Registration: clinicaltrials.gov Identifier: NCT01245686.

Introduction: In low-income and underserved populations, financial hardship and multiple competing roles and responsibilities lead to difficulties in lifestyle change for cardiovascular disease (CVD) prevention. To improve CVD prevention behaviors, we adapted, pilot-tested, and evaluated a problem-solving intervention designed to address barriers to lifestyle change., Methods: The sample consisted of 81 participants from 3 underserved populations, including 28 Hispanic or non-Hispanic white women in a western community (site 1), 31 African-American women in a semirural southern community (site 2), and 22 adults in an Appalachian community (site 3). Incorporating focus group findings, we assessed a standardized intervention involving 6-to-8 week group sessions devoted to problem-solving in the fall of 2009., Results: Most sessions were attended by 76.5% of participants, demonstrating participant adoption and engagement. The intervention resulted in significant improvement in problem-solving skills (P < .001) and perceived stress (P < .05). Diet, physical activity, and weight remained stable, although 72% of individuals reported maintenance or increase in daily fruit and vegetable intake, and 67% reported maintenance or increase in daily physical activity., Conclusion: Study results suggest the intervention was acceptable to rural, underserved populations and effective in training them in problem-solving skills and stress management for CVD risk reduction.

Background: Decision aids offer promise as a practical solution to improve patient decision making about coronary heart disease (CHD) prevention medications and help patients choose medications to which they are likely to adhere. However, little data is available on decision aids designed to promote adherence., Methods: In this paper, we report on secondary analyses of a randomized trial of a CHD adherence intervention (second generation decision aid plus tailored messages) versus usual care in an effort to understand how the decision aid facilitates adherence. We focus on data collected from the primary study visit, when intervention participants presented 45 minutes early to a previously scheduled provider visit; viewed the decision aid, indicating their intent for CHD risk reduction after each decision aid component (individualized risk assessment and education, values clarification, and coaching); and filled out a post-decision aid survey assessing their knowledge, perceived risk, decisional conflict, and intent for CHD risk reduction. Control participants did not present early and received usual care from their provider. Following the provider visit, participants in both groups completed post-visit surveys assessing the number and quality of CHD discussions with their provider, their intent for CHD risk reduction, and their feelings about the decision aid., Results: We enrolled 160 patients into our study (81 intervention, 79 control). Within the decision aid group, the decision aid significantly increased knowledge of effective CHD prevention strategies (+21 percentage points; adjusted p<.0001) and the accuracy of perceived CHD risk (+33 percentage points; adjusted p<.0001), and significantly decreased decisional conflict (-0.63; adjusted p<.0001). Comparing between study groups, the decision aid also significantly increased CHD prevention discussions with providers (+31 percentage points; adjusted p<.0001) and improved perceptions of some features of patient-provider interactions. Further, it increased participants' intentions for any effective CHD risk reducing strategies (+21 percentage points; 95% CI 5 to 37 percentage points), with a majority of the effect from the educational component of the decision aid. Ninety-nine percent of participants found the decision aid easy to understand and 93% felt it easy to use., Conclusions: Decision aids can play an important role in improving decisions about CHD prevention and increasing patient-provider discussions and intent to reduce CHD risk.

Background: While farmers' markets are a potential strategy to increase access to fruits and vegetables in rural areas, more information is needed regarding use of farmers' markets among rural residents. Thus, this study's purpose was to examine (1) socio-demographic characteristics of participants; (2) barriers and facilitators to farmers' market shopping in southern rural communities; and (3) associations between farmers' market use with fruit and vegetable consumption and body mass index (BMI)., Methods: Cross-sectional surveys were conducted with a purposive sample of farmers' market customers and a representative sample of primary household food shoppers in eastern North Carolina (NC) and the Appalachian region of Kentucky (KY). Customers were interviewed using an intercept survey instrument at farmers' markets. Representative samples of primary food shoppers were identified via random digit dial (RDD) cellular phone and landline methods in counties that had at least one farmers' market. All questionnaires assessed socio-demographic characteristics, food shopping patterns, barriers to and facilitators of farmers' market shopping, fruit and vegetable consumption and self-reported height and weight. The main outcome measures were fruit and vegetable consumption and BMI. Descriptive statistics were used to examine socio-demographic characteristics, food shopping patterns, and barriers and facilitators to farmers' market shopping. Linear regression analyses were used to examine associations between farmers' market use with fruit and vegetable consumption and BMI, controlling for age, race, education, and gender., Results: Among farmers' market customers, 44% and 55% (NC and KY customers, respectively) reported shopping at a farmers' market at least weekly, compared to 16% and 18% of NC and KY RDD respondents. Frequently reported barriers to farmers' market shopping were market days and hours, "only come when I need something", extreme weather, and market location. Among the KY farmers' market customers and NC and KY RDD respondents, fruit and vegetable consumption was positively associated with use of farmers' markets. There were no associations between use of farmers' markets and BMI., Conclusions: Fruit and vegetable consumption was associated with farmers' market shopping. Thus, farmers' markets may be a viable method to increase population-level produce consumption.

Objective: To examine the influence of farmers' market pricing and accessibility on willingness to shop at farmers' markets, among low-income women., Design: Qualitative interviews using scenarios with quantitative assessment of willingness to shop at farmers' markets given certain pricing and accessibility scenarios., Setting: Eastern North Carolina., Participants: A total of 37 low-income women of childbearing age (18-44 years) receiving family planning services at the health department., Phenomenon of Interest: Willingness to shop at a farmers' market., Analysis: Fisher's exact test was used to examine associations between willingness to shop at farmers' markets by urban/rural residence, race, and employment status. Direct quotations relevant to participants' use of farmers' markets were extracted based on a positive deviance framework., Results: Participants were increasingly willing to shop at the farmers' market when price savings increased and when the market was incrementally closer to their residence. Willingness was highest when there was at least a 20% price savings. Participants seemed to be influenced more by a visual representation of a greater quantity of produce received with the price savings rather than a quantitative representation of the money saved by the reduced price., Conclusions and Implications: Future farmers' market interventions should take into account these consumer level preferences., (Copyright © 2014 Society for Nutrition Education and Behavior. Published by Elsevier Inc. All rights reserved.)

Context: Obesity-prevention policies are needed, particularly in low-income rural areas of the southern United States, where obesity and chronic disease prevalence are high. In 2009, the Centers for Disease Control and Prevention issued the "Common Community Measures for Obesity Prevention" (COCOMO), a set of 24 recommended community-level obesity-prevention strategies., Objective: A variety of stakeholders in Lenoir County, North Carolina, were surveyed and interviewed, ranking the winnability, defined as feasibility and acceptability, of each of the 24 COCOMO-recommended strategies based on local culture, infrastructure, funding, and community support., Design: Mixed-methods., Setting: This study was part of the Heart Healthy Lenoir project, a community-based project to reduce cardiovascular disease risk and disparities in risk in Lenoir County, North Carolina., Participants: COCOMO assessments were conducted with 19 Community Advisory Council members and in-depth interviews were conducted with 11 community stakeholders. Heart Healthy Lenoir lifestyle intervention participants (n = 366) completed surveys wherein they ranked their support for 7 obesity-prevention strategies (based on the COCOMO strategies)., Main Outcome Measures: Ranking of obesity-prevention strategies., Results: Policies to improve physical activity opportunities were deemed the most winnable, whereas policies that would limit advertisement of unhealthy food and beverages were deemed the least winnable. The most winnable food-related strategy was improving mechanisms to procure food from local farms. Stakeholders perceived the public as unfavorably disposed toward government mandates, taxes, and incentives. Among Heart Healthy Lenoir participants, males indicated lower levels of support for COCOMO-related strategies than females, and African Americans indicated higher levels of support than white participants., Conclusion: The formative work presented here provides insight into the winnability of proposed obesity-prevention policy change strategies in Lenoir County, North Carolina.

Objective: We examined associations between access to food venues (farmers’ markets and supermarkets), shopping patterns, fruit and vegetable consumption and health indicators among women of reproductive age in eastern North Carolina, U.S.A., Design: Access to food venues was measured using a Geographic Information System incorporating distance, seasonality and business hours, to quantify access to farmers’ markets. Produce consumption was assessed by self-report of eating five or more fruits and vegetables daily. BMI and blood pressure were assessed by clinical measurements. Poisson regression with robust variance was used for dichotomous outcomes and multiple linear regression was used for continuous outcomes. As the study occurred in a university town and university students are likely to have different shopping patterns from non-students, we stratified analyses by student status., Setting: Eastern North Carolina., Subjects: Low-income women of reproductive age (18–44 years) with valid address information accessing family planning services at a local health department (n 400)., Results: Over a quarter reported ever shopping at farmers’ markets (114/400). A larger percentage of women who shopped at farmers’ markets consumed five or more fruits and vegetables daily (42.1%) than those who did not (24.0%; P < 0.001). The mean objectively measured distance to the farmers’ markets where women reported shopping was 11.4 (SD 9.0) km (7.1 (SD 5.6) miles), while the mean distance to the farmers’ market closest to the residence was 4.0 (SD 3.7) km (2.5 (SD 2.3) miles)., Conclusions: Among non-students, those who shopped at farmers’ markets were more likely to consume five or more servings of fruits and vegetables daily. Future research should further explore potential health benefits of farmers’ markets.

Background: Although lifestyle and medications are effective for coronary heart disease (CHD) risk reduction, few studies have examined the comparative effectiveness of various strategies for delivering high quality CHD risk reduction. In this paper, we report on the design and baseline characteristics of participants for just such a trial., Methods: We conducted a randomized trial of the same lifestyle and medication intervention delivered in two alternate formats: counselor-delivered or web-based. The trial was conducted at 5 diverse practices in a family medicine research network and included men and women age 35-79 who were at high risk of CHD events based on 10-year predicted Framingham risk of ≥10% or a known history of cardiovascular disease. After individual-level randomization, participants in both arms received a decision aid plus four intensive intervention visits and 3 maintenance visits over 12 months. The primary outcome was change in 10-year predicted CHD risk among patients without prior cardiovascular disease. Secondary outcomes, measured among all participants, included changes in CHD risk factors, cost-effectiveness, and acceptability at 4 and 12-month follow-up., Results: We randomized 489 eligible patients: 389 without and 100 with a known history of cardiovascular disease. Mean age was 62.3. 75% were white, 25% African-American. 45% had a college education. 88% had health insurance. Mean 10-year predicted CHD risk was 16.9%., Conclusion: We have successfully recruited a diverse sample of practices and patients that will provide a rich sample in which to test the comparative effectiveness of two strategies to implement high quality CHD prevention., (© 2013.)

Objective: To translate a behavioral weight loss intervention for mid-life, low-income women in real world settings., Design and Methods: In this pragmatic clinical trial, we randomly selected six North Carolina county health departments and trained their current staff to deliver a 16-session evidence-based behavioral weight loss intervention (special intervention, SI). SI weight loss outcomes were compared to a delayed intervention (DI) control group., Results: Of 432 women expressing interest, 189 completed baseline measures and were randomized within health departments to SI (N = 126) or DI (N = 63). At baseline, average age was 51 years, 53% were African American, mean weight was 100 kg, and BMI averaged 37 kg/m2 . A total of 96 (76%) SI and 55 (87%) DI participants returned for 5-month follow-up measures. The crude weight change was -3.1 kg in the SI and -0.4 kg in the DI group, for a difference of 2.8 kg (95% CI 1.4 to 4.1, p = 0.0001). Diet quality and physical activity improved significantly more in the SI group, and estimated intervention costs were $327 per participant., Conclusion: This pragmatic short-term weight loss intervention targeted to low-income mid-life women yielded meaningful weight loss when translated to the county health department setting., (Copyright © 2013 The Obesity Society.)